Medical Devices (Amendment) Rules, 2020

Feb 12, 2020 | by Avantis RegTech Legal Research Team

Industry Specific Compliance

The Ministry of Health and Family Welfare (MoHFW) on February 11, 2020, notifies the Medical Devices (Amendment) Rules, 2020 to further amend the Medical Devices Rules, 2017.

Under the amendment, a new Chapter IIIA related to “Registration of certain medical devices” has been inserted in the Medical Devices Rules, 2017. This Chapter shall be applicable to all devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals except the medical devices.

The Medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). The manufacturer of a medical device shall upload the information relating to that medical device for registration on the online system for medical devices. The manufacturer shall upload the name and address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device; details of medical device; certificate of compliance with respect to ISO : 13485 standard. The Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints.

These Rules shall come into effect from April 01, 2020.

[Notification No. G.S.R. 102 (E)]


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